Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)

Avanti Anesthesia651 enrolled

Overview

The investigators hypothesized that the combination of Valium, Tramadol and Zofran is superior to the substantially more expensive MKO melt in patient satisfaction after cataract surgery.

The MKO melt is being marketed as an anesthetic medication for cataract surgery that has the advantage that it eliminates the need for an IV in 85% of patients although that number was established anecdotally. This alternative, however, is very cost limiting.The investigators wanted to see if the current regimen (valium only) or a combination similar to the MKO melt (valium + tramadol + zofran) are as good if not better than the MKO melt for anesthesia and how many patients could have indeed gone with an intravenous line (didn't need any extra medications).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

651

Conditions

Cataract

Interventions

DiazepamDRUG

5 or 10mg

TramadolDRUG

50mg or 100mg

OndansetronDRUG

1 or two tabs

MKO meltDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * All patients scheduled to undergo cataract surgery with Drs. Mayo and Wade at Kirby Glen Surgery Center Exclusion Criteria: * Age \<18 years * Patient is not suitable for the medications for reasons such as unsteady gait, cane, wheelchair, severe dementia (unable to consent), terminal illness * Allergy to a medication in protocol

Locations (1)

Memorial Hermann Kirby Glen Surgery Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of patient who needed additional IV medication for cataract surgery

Patients who require IV medications for self-reported pain or anxiety during surgery.

Time frame: 1 day

Data from ClinicalTrials.gov

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